Efficacy and Safety of Endoscopic Variceal Ligation (EVL)... | NCT02739581

Studies
Efficacy and Safety of Endoscopic Variceal Ligation (EVL) Versus EVL Plus Non-selective B-blockers (NSBB) For Prevention of Variceal Rebleed and Non-bleed Related Complications in Patients With Advanced Cirrhosis

NCT02739581

Sponsor

Institute of Liver and Biliary Sciences, India

Status

Withdrawn

Last Update Posted

Oct 10, 2019Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Advanced Cirrhosis

Interventions

Endoscopic Variceal Ligation
Non selective beta blocker
Placebo

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of funds

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Apr 2019Estimated

Completion Date

Apr 2019Estimated

First Submitted Date

Apr 12, 2016

First Submission Date that Met QC Criteria

Apr 12, 2016

First Posted Date

Apr 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2019

Last Update Posted Date

Oct 10, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The patients will be randomized into two groups

Endoscopic Variceal Ligation with Non Selective Beta Blocker
Placebo with Endoscopic Variceal Ligation

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endoscopic variceal ligation with Non-selective B-blockers	Experimental		Procedure: Endoscopic Variceal Ligation Drug: Non selective beta blocker
Endoscopic variceal ligation with Placebo	Active Comparator		Procedure: Endoscopic Variceal Ligation Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endoscopic Variceal Ligation	Procedure		Endoscopic variceal ligation with Non-selective B-blockers Endoscopic variceal ligation with Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrence of variceal bleeding		12 months

Secondary Outcomes

Measure	Description	Time Frame
Recurrence of variceal bleeding		24 months
Survival		12 months
Survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients between 18 and 80 years old.
Clinical criteria and/or analytical, ultrasound and/or liver biopsy consistent with the diagnosis of liver cirrhosis.
Endoscopic Diagnosis of esophageal variceal bleeding within 5 days prior to study inclusion.
Written informed consent to participate in the study.
Child C status, CTP >10

Exclusion Criteria:

Pregnancy or lactation
Serum Creatinine > 2 mg/dl
Bleeding due to gastric varices.
Active infection or recent infection < 2 weeks
Presence of hepatocellular carcinoma or portal vein thrombosis
Active alcoholism
Pregnancy
HIV infection
Severe heart, respiratory or contraindications for beta blockers(severe chronic obstructive pulmonary disease, severe asthma, severe insulin-dependent diabetes mellitus, Brady arrhythmia)
Not giving consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr Ankur Jindal, MD	Institute of Liver and Biliary Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of liver and Biliary Sciences		New Delhi	National Capital Territory of Delhi	110070	India

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.